IV Acetaminophen as an Analgesic Adjunct
Purpose
To determine the efficacy of intravenous (IV) acetaminophen as an analgesic adjunct to IV hydromorphone in the treatment of acute severe pain in the elderly Emergency Department (ED) patients.
Condition
- Acute Pain
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV) opioids in the judgement of the treating attending physician
Exclusion Criteria
- Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics. - Prior adverse reaction to hydromorphone, morphine, or acetaminophen. - Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies. - Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception. - Systolic Blood Pressure (SBP) <100 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension. - Heart Rate (HR) < 60/min: Opioids can cause bradycardia. - Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled. - Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma. - Patients using transdermal pain patches
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental IV acetaminophen + 0.5 mg IV hydromorphone |
1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone |
|
Placebo Comparator Normal saline + 0.5 mg IV hydromorphone |
100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone |
|
More Details
- Status
- Completed
- Sponsor
- Montefiore Medical Center
Study Contact
Detailed Description
A randomized controlled trial to determine the efficacy of 1 gram IV acetaminophen as an analgesic adjunct to 0.5 mg IV hydromorphone in the treatment of acute severe pain in the elderly ED patients.